FUKUDA DENSHI MODEL FCP-2201 MODIFICATION

FUKUDA DENSHI MODEL FCP-2201 MODIFICATION is an FDA 510(k)-cleared medical device (K903704) manufactured by Fukuda Denshi USA, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 1990. Regulation: 8.